Cervical Traction for Itching

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must be taking: Gabapentin, Pregabalin

Disqualifiers: Spinal surgery, Uncontrolled diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether cervical traction (a gentle pulling on the neck) can reduce the need for GABAergic medications like gabapentin or pregabalin, often used to treat itchiness in the scalp, arms, and upper back. The goal is to determine if this method can more effectively relieve neuropathic itch (itch without a rash). Individuals with scalp, arm, or upper back itch who have maintained a stable dose of these medications for at least four weeks might be suitable candidates. The trial aims to find a new way to manage itchiness without heavy reliance on medications. As an unphased trial, it offers a unique opportunity to explore innovative treatment options for managing itchiness.

Will I have to stop taking my current medications?

The trial requires participants to be on a stable dosage of gabapentin or pregabalin for at least 4 weeks before joining. It does not specify if you need to stop other medications, but planned or anticipated use of prohibited medications during the study is not allowed.

What prior data suggests that cervical traction is safe for treating neuropathic itch?

Research has shown that cervical traction can reduce neck pain and disability. However, limited information exists on its long-term safety and effectiveness for other issues, such as itching. Some studies have explored cervical traction for certain types of itching related to nerve problems. These studies suggest potential benefits, but they lack detailed information on long-term safety.

While some reports support its use, clear information about side effects or negative outcomes remains scarce. Therefore, while cervical traction could be beneficial, discussing its potential risks and benefits with a doctor for a specific situation is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Cervical traction is unique because it offers a mechanical approach to treating itching, unlike the typical medications like antihistamines or corticosteroids that are commonly used. This method could potentially provide relief without the need for additional drugs, which is especially beneficial for patients already taking gabapentin or pregabalin. Researchers are excited about cervical traction because it introduces a non-pharmacological option that might help alleviate symptoms by physically addressing nerve-related discomfort, offering a new avenue for those with persistent itchiness.

What evidence suggests that cervical traction is effective for neuropathic itch?

Research suggests that cervical traction, which participants in this trial will receive, might alleviate itching caused by nerve issues affecting the scalp, arms, or upper back. One study found that nerve pressure often links to itching in certain areas, indicating that relieving this pressure could help. In another case, a patient with similar symptoms experienced significant relief after treating their nerve problems. Although direct evidence for cervical traction specifically is limited, these findings suggest that reducing nerve pressure might ease itching. Overall, by relieving nerve pressure, itching could be reduced. ^{3 6 7 8 9}

Who Is on the Research Team?

David Swanson

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have eczema or itching on the scalp, arms, and upper back without primary skin lesions. Participants must be on a stable dose of gabapentin or pregabalin for at least 4 weeks and able to follow study procedures. Pregnant individuals, those with severe illnesses that affect participation, or conditions making neck traction unsafe cannot join.

Inclusion Criteria

I can attend all clinic visits and follow study procedures.

Persons willing and able to understand and complete study-related questionnaires

I have itching on my scalp, arms, and upper back without any skin rash.

Exclusion Criteria

I cannot take gabapentin or pregabalin due to my medical condition.

Current enrollment in physical therapy with exercises addressing the cervical spine

Currently pregnant or breastfeeding or plans to become pregnant or breastfeed during the participation in the study. Persons of childbearing age who are not on reliable contraception will be considered on a case-by-case basis

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cervical traction to reduce GABAergic medication use

12 weeks

Home-based treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cervical Traction

Trial Overview

The study tests if cervical traction can reduce the need for GABAergic medications like gabapentin or pregabalin in treating neuropathic itch. It involves regular clinic visits and questionnaire completion to assess the effectiveness of using a cervical traction device.

How Is the Trial Designed?

Group I: Cervical Traction Group Experimental Treatment 1 Intervention

Patients who are on a stable dosage of gabapentin or pregabalin for scalp, arm or upper back pruritus without primary rash

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

In a randomized controlled trial involving 79 patients with chronic neck pain, intermittent cervical traction did not show significant improvements compared to infrared irradiation alone in reducing pain or improving neck function over a 12-week follow-up.

Both treatment groups exhibited similar outcomes on pain and neck function measurements, indicating that intermittent cervical traction may not be more effective than the control treatment for chronic neck pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial on the efficacy of intermittent cervical traction for patients with chronic neck pain. Chiu, TT., Ng, JK., Walther-Zhang, B., et al.[2011]

In a randomized clinical trial involving 100 patients with cervical spine disorders, all treatment groups showed significant improvement over 6 weeks, indicating that traction therapy can be beneficial for neck pain.

Patients receiving intermittent traction specifically demonstrated greater improvements in pain relief and range of motion compared to those who received no traction, highlighting its efficacy in treating cervical spine issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cervical spine disorders. A comparison of three types of traction. Zylbergold, RS., Piper, MC.[2011]

Cervical traction can be beneficial for certain conditions, and there are clear social and economic advantages to performing this treatment at home.

A new technique for cervical traction is introduced that applies traction in a flexed position instead of the traditional extended position, potentially improving comfort and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cervical traction in the home. Laurin, CA.[2018]

The new cervical traction system allows for precise application of traction to specific spinal segments, which can reduce the force needed and lower the risk of injury compared to traditional methods.

Patient compliance is reportedly higher with this system, leading to increased treatment effectiveness, although further controlled studies are necessary to confirm its safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Goodley polyaxial cervical traction. A new approach to a traditional treatment. Walker, GL.[2019]

Cervical traction using weights of 10% to 20% of body weight is safe for young women, showing no significant adverse effects on cardiovascular function during treatment.

However, using a heavier traction weight of 30% of body weight can lead to elevated blood pressure and heart rate variability, suggesting it should be avoided, particularly in patients with cardiovascular issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in blood pressure and related autonomic function during cervical traction in healthy women. Tsai, CT., Chang, WD., Kao, MJ., et al.[2017]

Intermittent cervical traction was successfully used to treat 4 patients with cervical radiculopathy caused by large-volume herniated disks, leading to complete symptom resolution within 3 weeks.

Cervical traction may be an effective treatment option for managing radiculopathy from herniated disks, even in cases of recurrence, as demonstrated by one patient who was successfully treated again after 16 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent cervical traction for cervical radiculopathy caused by large-volume herniated disks. Constantoyannis, C., Konstantinou, D., Kourtopoulos, H., et al.[2019]

A new 3-point bending cervical traction method combined with spinal manipulation significantly reduced pain in patients with cervicogenic pain, with visual analog scale (VAS) ratings dropping from 4.3 pretreatment to 1.6 posttreatment.

The traction treatment also led to significant improvements in cervical alignment, with notable increases in lordosis and stability of these improvements maintained at a 15.5-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new 3-point bending traction method for restoring cervical lordosis and cervical manipulation: a nonrandomized clinical controlled trial. Harrison, DE., Cailliet, R., Harrison, DD., et al.[2019]

In a study of 39 patients with cervical radiculopathy, both manual and mechanical intermittent cervical traction significantly improved cervical pain, radicular pain, and disability compared to conventional rehabilitation alone after treatment.

Improvements in pain and disability were sustained for up to 6 months in the traction groups, indicating that these methods are effective components of a multimodal rehabilitation approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of intermittent cervical traction in recent cervical radiculopathy. Jellad, A., Ben Salah, Z., Boudokhane, S., et al.[2009]

A new method of cervical traction allows for continuous and comfortable treatment while patients can choose their preferred position in bed, enhancing their comfort during therapy.

This approach may improve patient compliance and overall effectiveness of cervical traction therapy by allowing greater freedom of movement and positioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Good Samaritan cervical traction. Borden, JN.[2019]

In a study of 35 patients with cervical pain from degenerative changes, traction treatment combined with medication led to significant improvements, reducing treatment time and extending the duration of relief.

The most common side effect observed from the traction method was vertigo, indicating a need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Combined pharmacological and traction treatment in cases of painful syndromes of the cervical spine with degenerative and deformative changes]. Eljasz, L., Krzysztoń-Przekop, K.[2015]

Cervical traction therapy, commonly used for cervical spine issues, can lead to serious complications, including a rare case of unilateral facial nerve paralysis after 4 weeks of treatment.

The facial nerve paralysis in this case was likely caused by improper harness placement, leading to nerve compression, but symptoms improved with treatment and cessation of therapy, highlighting the need for careful monitoring during cervical traction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facial nerve paralysis after cervical traction. So, EC.[2016]

A clinical trial involving 40 patients with chronic cervical radiculopathy found that applying intermittent cervical traction in a supine position significantly reduced neck disability compared to traction in a sitting position, with a notable difference in Neck Disability Index scores after 3 weeks of treatment.

The study suggests that the supine position is more effective for managing cervical radiculopathy, highlighting the importance of treatment positioning in rehabilitation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of intermittent Cervical Traction in sitting Vs. Supine position for the management of Cervical Radiculopathy. Khan, RR., Awan, WA., Rashid, S., et al.[2022]

In a retrospective study of 58 outpatients with cervical pain, a simple over-the-door home cervical traction method provided symptomatic relief for 81% of patients, particularly effective for those with mild to moderate cervical spondylosis.

The study showed that 100% of patients with mild symptoms (Grade 1) and 90% of those with radiculopathy (Grade 3) experienced improvement, suggesting that this method may be a safe and effective treatment option, although further prospective studies are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of home cervical traction therapy. Swezey, RL., Swezey, AM., Warner, K.[2022]

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7 Two case reports found in the literature noted that cervical spine manipulation and cervical traction yielded positive results. 20, 21 It ...